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A Study of the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prevention of Migraine
This study has been completed.
First Received: October 7, 2005   Last Updated: September 24, 2008   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00236561
  Purpose

The purpose of this study is to evaluate the safety and efficacy of two doses of topiramate (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The study will also assess dose response relationship of topiramate, estimate the relative efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect of migraine prevention with topiramate versus placebo on Health Related Quality of Life.


Condition Intervention Phase
Headache
Classic Migraine
Common Migraine
Migraine
Drug: topiramate, propranolol
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prophylaxis of Migraine

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change in the monthly (28 days) migraine period rate from the Prospective Baseline Period to the Core Double-Blind Phase.

Secondary Outcome Measures:
  • Proportion of patients responding to treatment.Change from Baseline Phase to Core Double-Blind Phase in number of monthly migraine attacks,monthly migraine days, number of days/month requiring rescue medication,and Health Related Quality of Life measures

Estimated Enrollment: 568
Study Start Date: December 2000
Estimated Study Completion Date: December 2002
Detailed Description:

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of two doses of topiramate versus placebo and propranolol in the prevention of migraine headaches. The study consists of 4 phases: Baseline Phase (evaluation of eligibility criteria and tapering of any migraine prophylaxis medications patients are taking), Core Double-Blind Phase (patients are randomized to receive either 100 milligrams[mg]/day topiramate, 200mg/day topiramate, 160mg/day propranolol or placebo for a total of 26 weeks), Blinded Extension Phase (patients continue the same dose of medication until the sponsor terminates the study or a patient withdraws from the study), and Taper/Exit Phase (medication of patients exiting from the study is tapered over 7 weeks). The primary hypothesis is that one or two topiramate doses (100, 200 mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in the monthly (28 days) migraine period rate from the prospective Baseline Phase to the Core Double-Blind Phase.

Oral medication (100 milligrams[mg]/day topiramate, 200mg/day topiramate, 160mg/day propranolol, or placebo) during the 26-weeks Core Double-Blind Phase. Doses may be continued until the termination of the study or withdrawal by the patients during the Blinded Extension Phase.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year prior to the study
  • Between 3 to 12 migraine periods and no greater than 15 headache days (migraine and non-migraine) per month during the Baseline Phase
  • No clinically significant abnormalities on neurological exams, electrocardiogram (ECG) or clinical laboratory test results at baseline
  • Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

  • Patients with headaches other than migraine
  • Patients with episodic tension or sinus headaches
  • Onset of migraine after age of 50 years
  • Patients who have failed more than two adequate regimens for migraine prophylaxis
  • Patients who overuse pain medications or certain other medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236561

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Publications:
Study ID Numbers: CR003205
Study First Received: October 7, 2005
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00236561     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Topiramate
Classic Migraine
Migraine
Prophylaxis
Propranolol
Common Migraine
Headache
Prevention

Additional relevant MeSH terms:
Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Headache Disorders, Primary
Pain
Brain Diseases
Neuroprotective Agents
Headache Disorders
Signs and Symptoms
Propranolol
Migraine Disorders
Therapeutic Uses
Headache
Topiramate
Adrenergic beta-Antagonists
Migraine with Aura
Anti-Arrhythmia Agents
Migraine without Aura
Nervous System Diseases
Central Nervous System Diseases
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Neurologic Manifestations
Adrenergic Antagonists
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009